Avastin for breast cancer? FDA hears patients, experts debate drug
(CBS/AP) Cancer patients pleaded with the FDA to continue to approve Avastin for breast cancer as the agency held rare hearings to determine the fate of the top-selling breast cancer drug.
"I am alive due to Avastin," 66-year-old Patricia Howard told the agency. "I'm a wife, mother, sister, aunt and granny. I'm not just a statistic. It's in your hands to make sure I don't become one."
Testimony from patients kicked off the two-day meeting to hear Avastin's maker, the Swiss pharmaceutical giant Roche, appeal the FDA proposal to remove the breast cancer indication for Avastin. Last December the FDA proposed that Avastin's indication for breast cancer be rescinded while keeping the drug on the market for cancers of the colon, lung, brain, and kidney.
But some experts urged the FDA not to undermine its own credibility by endorsing a drug when research has shown that the drug is not particularly effective.Avastin won U.S. clearance for breast cancer in 2008 based on a study showing the drug stalled cancer growth by 5.5 months. Later studies found only a one- to three-month delay in breast cancer growth. None of the studies showed that Avastin extended the lives of patients with advanced breast cancer, and some patients experienced severe side effects, including blood clots and holes in the stomach and intestines.
Stripping the breast cancer indication for Avastin would not prevent doctors from using it. But without FDA approval, insurers may refuse to pay Avastin's $8,000-a-month price tag. An estimated 17,000 women now use the medicine for breast cancer.
The appeals panel is expected to make its recommendation at the end of the hearing Wednesday. FDA Commissioner Margaret Hamburg will make the final decision.